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Sponsors and Collaborators: |
Amylin Pharmaceuticals, Inc. Eli Lilly and Company |
Information provided by: | Amylin Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00500370 |
This is a multicenter study designed to compare the effect of exenatide plus a lifestyle modification plan versus placebo plus a lifestyle modification plan on weight loss in non-diabetic, obese subjects.
Condition | Intervention | Phase |
Obesity |
Drug: exenatide Drug: placebo |
Phase II |
MedlinePlus related topics: | Obesity Weight Control |
Drug Information available for: | Exenatide |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Pilot Study of Effects of Exenatide on Body Weight in Non-Diabetic, Obese Patients |
Estimated Enrollment: | 160 |
Study Start Date: | June 2007 |
Study Completion Date: | February 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
Group A: Experimental |
Drug: exenatide
subcutaneous injection (5mcg or 10mcg), twice a day
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Group B: Placebo Comparator |
Drug: placebo
subcutaneous injection (equivalent volume to active dose), twice a day
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |||||
Research Site | |||||
Tucson, Arizona, United States | |||||
Research Site | |||||
Peoria, Arizona, United States | |||||
United States, California | |||||
Research Site | |||||
Santa Ana, California, United States | |||||
United States, Indiana | |||||
Research Site | |||||
Indianapolis, Indiana, United States | |||||
United States, Kansas | |||||
Research Site | |||||
Topeka, Kansas, United States | |||||
Research Site | |||||
Wichita, Kansas, United States | |||||
United States, Louisiana | |||||
Research Site | |||||
Baton Rouge, Louisiana, United States | |||||
United States, Missouri | |||||
Research Site | |||||
St. Louis, Missouri, United States | |||||
United States, Oklahoma | |||||
Research Site | |||||
Oklahoma City, Oklahoma, United States | |||||
United States, South Carolina | |||||
Research Site | |||||
Goose Creek, South Carolina, United States | |||||
Research Site | |||||
Spartanburg, South Carolina, United States | |||||
United States, Texas | |||||
Research Site | |||||
Dallas, Texas, United States | |||||
Research Site | |||||
San Antonio, Texas, United States | |||||
United States, Washington | |||||
Research Site | |||||
Renton, Washington, United States | |||||
Puerto Rico | |||||
Research Site | |||||
San Juan, Puerto Rico | |||||
Research Site | |||||
Ponce, Puerto Rico |
Amylin Pharmaceuticals, Inc. |
Eli Lilly and Company |
Study Director: | James Malone, MD | Eli Lilly and Company |
Responsible Party: | Eli Lilly and Company ( James Malone, MD, Study Director ) |
Study ID Numbers: | H8O-MC-GWBP |
First Received: | July 10, 2007 |
Last Updated: | March 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00500370 |
Health Authority: | United States: Food and Drug Administration |
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